PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION— 510(k) K020055
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K020055 for PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION, Substantially Equivalent on 2002-03-15. Applicant: Philips Medical Systems.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.